Yamashita Keita, Takebayashi Shiori, Murata Wataru, Hirai Nao, Ito Yui, Mitsui Mayuka, Saito Mina, Sato Kei, Terada Miyuki, Niizeki Noriyasu, Suzuki Akira, Ogitani Kenya, Fujikawa Toshihiko, Komori Marie, Inoue Nozomi, Arai Norimitsu, Maekawa Masato
Department of Laboratory Medicine, Hamamatsu University School of Medicine, Hamamatsu 431-3192, Japan.
Diagnostic Products Development, Department Research & Development, Sekisui Medical Co., Ltd., Tokyo 103-0027, Japan.
Diagnostics (Basel). 2023 Sep 13;13(18):2935. doi: 10.3390/diagnostics13182935.
Thymus- and activation-regulated chemokine (TARC, also known as CCL17) is used as a biomarker for atopic dermatitis. The methods currently used for its measurement are complex, time-consuming, and require large machinery, warranting the need for a method that is simple, has a quick turnaround time, and requires less complex machinery. We evaluated the analytical performance of a novel latex turbidimetric immunoassay method, "Nanopia TARC", on 174 residual serum samples from patients with skin or allergic diseases. This evaluation included the assessment of the limit of blank/detection/quantification (LOB/D/Q), precision, accuracy, linearity, interference, and commutability between Nanopia TARC and "HISCL TARC", based on the chemiluminescent enzyme immunoassay (CLEIA) method. The LOB/D/Q values were 13, 57, and 141 pg/mL, respectively. The coefficient of variation of the repeatability was 0.9-3.8%, and that of the intermediate precision was 2.1-5.4%. The total error of the accuracy was 1.9-13.4%. The linearity was 141 and 19,804 pg/mL for TARC. The correlation coefficient between Nanopia TARC and HISCL TARC determined using the Passing-Bablok regression analysis was 0.999. Furthermore, the concordance of diagnostic criteria with AD was 92%. Nanopia TARC was confirmed to have the same analytical performance for TARC measurement as the existing CLEIA method.
胸腺和激活调节趋化因子（TARC，也称为CCL17）被用作特应性皮炎的生物标志物。目前用于测量它的方法复杂、耗时，且需要大型仪器，因此需要一种简单、周转时间短且所需仪器不太复杂的方法。我们在174份来自皮肤或过敏性疾病患者的剩余血清样本上评估了一种新型乳胶比浊免疫分析方法“Nanopia TARC”的分析性能。该评估包括基于化学发光酶免疫分析（CLEIA）方法对空白/检测/定量限（LOB/D/Q）、精密度、准确度、线性、干扰以及Nanopia TARC与“HISCL TARC”之间的互换性进行评估。LOB/D/Q值分别为13、57和141 pg/mL。重复性变异系数为0.9 - 3.8%，中间精密度变异系数为2.1 - 5.4%。准确度的总误差为1.9 - 13.4%。TARC的线性范围为141至19,804 pg/mL。使用Passing - Bablok回归分析确定的Nanopia TARC与HISCL TARC之间的相关系数为0.999。此外，与特应性皮炎诊断标准的一致性为92%。已证实Nanopia TARC在测量TARC方面具有与现有的CLEIA方法相同的分析性能。
